Official Title

Summary:

In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC)
planned to have hormonal treatment, will undergo conventional imaging and functional imaging
prior to treatment and post treatment to determine if changes in imaging results will be
prognostic of outcome. Patients will have a clinical follow-up every 3 months post
randomization for one year and followed for survival at Years 2 and 3.

In this study 30 men, with advanced metastatic CRPC intended to have abiraterone acetate or
enzalutamide hormonal treatment will undergo conventional imaging including a 99mTc-Methyl
diphosphonate (MDP) bone scan and Computed Tomography (CT) of the abdomen and pelvis, and
functional imaging with 18F-fluorodeoxyglucose (FDG) PET-CT and
2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic
acid (18F-DCFPyL) PET-CT one to four weeks prior to hormonal treatment and approximately 10
weeks post hormonal treatment.

Prostate Specific Antigen (PSA) will also be obtained at baseline and every three months in
the first year. Baseline imaging of disease and changes between baseline and follow-up
imaging on 18F-FDG PET-CT and 18F-DCFPyL PET-CT will be compared with standard of care
imaging (99mTc-MDP bone scan and CT of the abdomen/pelvis) as well as with clinical
evaluation including response to therapy and progression of disease.

This information could be used by clinicians to guide androgen receptor (AR) - targeted
therapy. Patients will have a clinical follow-up every 3 months post randomization for one
year and will be followed for survival at Years 2 and 3.